跳至主要内容
临床试验/CTRI/2020/03/024100
CTRI/2020/03/024100已完成4 期

Single blind, randomized study comparing clinical equivalence of Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk suture, for primary closure of mucosa in subjects undergoing planned surgical removal of mesioangular impacted mandibular third molar

Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd0 个研究点目标入组 132 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
132

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Subjects, both male and female, aged 20-40 years
  • 2. Subjects having mesioangular impacted mandibular 3rd molar
  • 3. Subjects requiring mucosal suturing
  • 4. Subjects who have given informed consent
  • 5. Subjects classified under ASA I and II

排除标准

  • 1. Subjects having infected molar teeth or complicated impacted 3rd molar
  • 2. Pregnant or lactating women
  • 3. Subjects with history of allergy to silk or similar products
  • 4. Subjects on drugs like aspirin, blood thinners and anticoagulant therapy
  • 5. Subjects receiving any type of local and systemic drugs which can produce inflammation in gingival tissue
  • 6. Subjects with history of systemic diseases such as diabetes mellitus, tuberculosis, bleeding disorders, osteoporosis, unstable or life-threatening conditions, those undergoing radiation therapies.
  • 7. Subjects those who had the habit of drug abuse
  • 8. Subjects already participating in another trial
  • 9. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
  • 10. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
  • 11. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
  • 12. Other indication or the reason for exclusion, in the opinion of investigator

研究者

发起方
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd

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